NCT07378761

Brief Summary

The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period. The trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could be superior to corticosteroids for treating ICI-related cholestatic hepatitis, based on its established use in primary biliary cholangitis and a favorable tolerance profile compared to corticosteroids.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
27mo left

Started Feb 2026

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Aug 2028

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Immune-Mediated Cholestasis

Keywords

DILIImmune checkpoint inhibitorsCancerCholestatic hepatitis

Outcome Measures

Primary Outcomes (1)

  • Improvement of at least 25% in liver function tests on day 21 after randomization

    The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) on Day 21 after randomization.

    21 days after randomization

Secondary Outcomes (4)

  • Rate of Hepatitis Resolution at 6 Months

    6 Months after randomization

  • Time to Hepatitis Resolution

    From Randomization to end of follow-up at 12 months

  • Tolerance to UDCA and/or Corticosteroids

    From treatment initiation following the randomization to end of follow-up at 12 months

  • Resumption of immunotherapy

    Within 12 months after randomization

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients randomized to the experimental arm will receive ursodeoxycholic acid (UDCA) as initial treatment for hepatitis. After evaluation of the primary endpoint at Day 21, UDCA treatment will be continued for a total duration of 6 months. In case of lack of response to UDCA, patients will continue UDCA and will additionally receive corticosteroids which represent the reference treatment.

Drug: UDCA (Ursodeoxycholic acid)

Control arm

ACTIVE COMPARATOR

Patients randomized to the control arm will receive the reference treatment, corticosteroids. Corticosteroids will be given at a dose of 0.5-1 mg/kg/day for 21 days, followed by tapering in weekly steps of 10 mg until treatment discontinuation. At Day 21, in case of lack of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroid tapering will continue, and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.

Drug: Corticosteroids (Reference Treatment)

Interventions

UDCA (Ursodeoxycholic acid)DRUG

Ursodeoxycholic acid (UDCA) will be administered orally at an initial dose of 13-15 mg/kg/day, divided into two daily doses. After assessment of the primary endpoint at Day 21, UDCA will be continued for a total treatment duration of 6 months. In case of absence of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroids which represent the reference treatment, will be added at a dose of 0.5-1 mg/kg.

Experimental arm
Corticosteroids (Reference Treatment)DRUG

Corticosteroids will be administered orally at a dose of 0.5-1 mg/kg/day for 21 days, followed by a tapering schedule of 10 mg per week until treatment discontinuation. At Day 21, if there is no adequate response (defined as less than 25% decrease in alkaline phosphatase and/or gamma-glutamyl transferase from baseline), the corticosteroid taper will continue and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ≥18 years old
  • Any type of cancer except hepatocellular or cholangiocarcinoma
  • At least one ICI injection
  • Cholestatic hepatitis Grade CTC-AE 3 or 4

You may not qualify if:

  • Ongoing corticosteroids treatment
  • Other causes of hepatitis
  • Cirrhosis
  • ICI for hepatocellular carcinoma or cholangiocarcinoma
  • Biliary obstruction
  • Medical contraindication to corticosteroids or UDCA
  • Mixed or hepatocellular hepatitis
  • Total bilirubin \> 1,5 ULN, Prothrombin rate \< 70%
  • Medical contraindication to MRI or liver biopsy
  • Oher serious side effects requiring corticosteroids
  • Pregnant and breast-feeding patients
  • Patients under articles L1121-5 to 8 of the public health code
  • Lack of informed consent
  • Patients not affiliated with French social security system
  • Patients uncapable of understanding french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Bordeaux

Bordeaux, France

Location

HCL Croix Rousse

Lyon, France

Location

CHU Montpellier

Montpellier, France

Location

APHP Paul Brousse

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ursodeoxycholic AcidAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Dr. Meunier

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. MEUNIER

CONTACT

+33467330224lucy.meunier@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

FR(6)